A panel of advisers to the Food and Drug Administration unanimously voted to back COVID-19 vaccines from Pfizer and Moderna for children under five, bringing shots for America’s youngest children one step closer to a reality.
The group ruled in separate 21-0 votes that the benefits of the vaccines greatly outweigh the risks. “This is a long-awaited vaccine,” Dr. Jay Portnoy, a member of the panel who works at Children’s Hospital in Kansas City, Missouri, said. “There are so many parents who are absolutely desperate to get this vaccine and I think we owe it to them to give them a choice to have the vaccine if they want to.”
Wednesday’s news will no doubt be a source of great relief for parents of children under 5, the last remaining group in the United States not eligible for vaccination. If the FDA agrees with the recommendation from its panel of independent adviers, then the matter moves over to the Centers for Disease Control and Prevention.
The CDC’s panel of advisers will meet Saturday to discuss whether or not to recommend the vaccines for kids under 5, a group of roughly 18 million. Assuming CDC Director Dr. Rochelle Walensky signs off on their recommendation, shots could begin as soon as early next week.
Pfizer’s vaccine is for children 6 months through 4 years; Moderna’s vaccine is for 6 months through 5 years. Moderna’s shots are one-quarter the dose of the company’s adult shots. Two doses appeared strong enough to prevent severe illness but only about 40% to 50% effective at preventing milder infections. Moderna has added a booster to its study and expects to eventually offer one. Pfizer’s shots are just one-tenth its adult dose. Pfizer and partner BioNTech found that two shots didn’t provide enough protection in testing, so a third was added during the omicron wave.
Pfizer’s submitted data found no safety concerns and suggested that three shots were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 COVID-19 cases; the calculation could change as more cases occur in the company’s ongoing studies.
Dr. Peter Marks, FDA’s vaccine chief, opened the meeting with data showing a “quite troubling surge” in young children’s hospitalizations during the omicron wave, and noted 442 children under 4 have died during the pandemic. That’s far fewer than adult deaths, but should not be dismissed in considering the need for vaccinating the youngest kids, he said. “Each child that’s lost essentially fractures a family,” Marks said.
FDA reviewers said both brands appear to be safe and effective for children as young as 6 months old in analyses posted ahead of the all-day meeting. Side effects, including fever and fatigue, were generally minor in both, and less common than seen in adults.
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